PMID- 30874328 OWN - NLM STAT- MEDLINE DCOM- 20200323 LR - 20200323 IS - 1365-2036 (Electronic) IS - 0269-2813 (Linking) VI - 49 IP - 8 DP - 2019 Apr TI - Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry. PG - 1052-1059 LID - 10.1111/apt.15222 [doi] AB - BACKGROUND: Glecaprevir/pibrentasvir is a pangenotypic direct-acting antiviral regimen approved for treating adults chronically infected with hepatitis C virus (HCV). There are limited real-world data on glecaprevir/pibrentasvir to date. AIM: To evaluate the effectiveness and safety of glecaprevir/pibrentasvir under real-world conditions in the German Hepatitis C-Registry (DHC-R). METHODS: The DHC-R is an ongoing, non-interventional, multicentre, prospective, observational cohort study that monitors patients with chronic HCV infection. Data were collected from patients who initiated glecaprevir/pibrentasvir and completed a screening visit on or after 2 August 2017. The primary effectiveness endpoint was sustained virological response at post-treatment Week 12 (SVR12). Safety and tolerability were also assessed. RESULTS: As of 15 July 2018, 586 patients received glecaprevir/pibrentasvir and had documented SVR12 data, treatment discontinuation, loss to follow-up or HCV reinfection. Five hundred and fifty-two patients (94%) received on-label treatment. At baseline, most on-label patients were infected with HCV genotype 1 (53%) or 3 (33%), HCV treatment-naive (90%), without cirrhosis (94%), and treated for 8 weeks (93%). Five hundred and thirty-four patients (96.7%) achieved SVR12 (intention-to-treat [ITT] analysis). By modified ITT analysis (excluding patients who discontinued and did not achieve SVR12 or patients lost to follow-up), the SVR12 rate was 99.4% (n/N = 534/537). There was one documented virological failure (relapse) and two documented HCV reinfections. One hundred and forty-two (26%) adverse events (AEs) and 9 (2%) serious AEs occurred; 2 (<1%) AEs led to treatment discontinuation. All patients treated off-label (N = 34) achieved SVR12. CONCLUSION: Glecaprevir/pibrentasvir was highly effective and well tolerated under real-world conditions. Clinical trial number: DRKS00009717 (German Clinical Trials Register, DRKS). CI - (c) 2019 John Wiley & Sons Ltd. FAU - Berg, Thomas AU - Berg T AUID- ORCID: 0000-0001-5551-6811 AD - Section of Hepatology, University Hospital Leipzig, Leipzig, Germany. FAU - Naumann, Uwe AU - Naumann U AD - UBN/Practice, Berlin, Germany. FAU - Stoehr, Albrecht AU - Stoehr A AD - IFI Studien und Projekte GmbH, Hamburg, Germany. FAU - Sick, Christoph AU - Sick C AD - Praxisonkologie Bremen, Bremen, Germany. FAU - John, Christine AU - John C AD - Practice Dr. med. C. John, Berlin, Germany. FAU - Teuber, Gerlinde AU - Teuber G AD - Practice PD Dr. med. G. Teuber, Frankfurt, Germany. FAU - Schiffelholz, Willibold AU - Schiffelholz W AD - Gastroenterologische Schwerpunktpraxis, Augsburg, Germany. FAU - Mauss, Stefan AU - Mauss S AD - Center for HIV and Hepatogastroenterology, Dusseldorf, Germany. FAU - Lohmann, Kristina AU - Lohmann K AD - AbbVie Germany GmbH & Co. KG, Wiesbaden, Germany. FAU - Konig, Bettina AU - Konig B AD - AbbVie Germany GmbH & Co. KG, Wiesbaden, Germany. FAU - Pangerl, Andreas AU - Pangerl A AD - AbbVie Germany GmbH & Co. KG, Wiesbaden, Germany. FAU - Niederau, Claus AU - Niederau C AD - Katholisches Klinikum Oberhausen, St. Josef-Hospital, Klinik fur Innere Medizin, Akademisches Lehrkrankenhaus der Universitat Duisburg-Essen, Oberhausen, Germany. LA - eng GR - German Center for Infection Research/International GR - AbbVie Deutschland GmbH & Co. KG/International GR - Bristol-Myers Squibb GmbH & Co. KGaA/International GR - Gilead Sciences GmbH/International GR - Janssen-Cilag GmbH/International GR - MSD Sharp & Dohme GmbH/International GR - Roche Pharma AG/International PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20190315 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Antiviral Agents) RN - 0 (Benzimidazoles) RN - 0 (Drug Combinations) RN - 0 (Pyrrolidines) RN - 0 (Quinoxalines) RN - 0 (Sulfonamides) RN - 0 (glecaprevir and pibrentasvir) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiviral Agents/*administration & dosage/therapeutic use MH - Benzimidazoles/*administration & dosage MH - Cohort Studies MH - Drug Combinations MH - Female MH - Genotype MH - Hepacivirus/genetics MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Pyrrolidines/*administration & dosage MH - Quinoxalines/*administration & dosage MH - Registries MH - Sulfonamides/*administration & dosage MH - Sustained Virologic Response MH - Young Adult EDAT- 2019/03/16 06:00 MHDA- 2020/03/24 06:00 CRDT- 2019/03/16 06:00 PHST- 2018/12/19 00:00 [received] PHST- 2018/12/30 00:00 [revised] PHST- 2019/02/18 00:00 [accepted] PHST- 2019/03/16 06:00 [pubmed] PHST- 2020/03/24 06:00 [medline] PHST- 2019/03/16 06:00 [entrez] AID - 10.1111/apt.15222 [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2019 Apr;49(8):1052-1059. doi: 10.1111/apt.15222. Epub 2019 Mar 15.